The Efficacy and Safety Study of High Dose Donepezil in P... | NCT02415062

Studies
The Efficacy and Safety Study of High Dose Donepezil in Parkinson's Disease With Dementia

NCT02415062

Sponsor

Inje University

Status

Unknown status

Last Update Posted

Aug 6, 2015Estimated

Enrollment

150Estimated

Phase

Phase 2

Conditions

Parkinson's Disease

Interventions

Donepezil

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Oct 2016Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Mar 14, 2015

First Submission Date that Met QC Criteria

Apr 8, 2015

First Posted Date

Apr 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2015

Last Update Posted Date

Aug 6, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study to evaluate the safety and efficacy of high-dose donepezil (23mg) in Parkinson's disease with dementia compared to standard dose donepezil.

Detailed Description

This study is open-label, prospective, randomized paralleled study. The investigators evaluate the efficacy of high-dose donepezil in patients with Parkinson's disease with dementia (PDD) who have taken standard donepezil (10mg) for 12 weeks. The participants, who sign the informed consent, are assigned into two groups randomly (high-dose donepezil group and standard donepezil group). All participants will be maintained the medication for 24 weeks and assessed cognitive function at 24 weeks. They will visit to clinic for 3 times (4, 12, 24 weeks) to assess cognitive function and adverse event. After the end of study, all participants were administrated by standard dose donepezil again.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
high dose donepezil (23mg)	Experimental	Patients with dementia in Parkinson's disease, who are treated with high dose donepezil (23mg)	Drug: Donepezil
standard dose denepezil (10mg)	Active Comparator	Patients with dementia in Parkinson's disease, who are treated with standard dose donepezil (10mg)	Drug: Donepezil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Donepezil	Drug	23mg/day for 24 weeks versus 10mg/day for 24 weeks	high dose donepezil (23mg) standard dose denepezil (10mg)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Korean Mini-Mental State Examination-2 (MMSE-2)	scale for general cognitive function, We used Korean version of MMSE-2 from PAR company	24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Korean-Instrumental Activities of Daily Living	scales for activities daily living	24 weeks
Clinical dementia rating	scales for activities of daily living

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria :

Patients diagnosed as Parkinson's disease according to Queen Brain Bank criteria
Patients who have been diagnosed as dementia after diagnosing Parkinson's disease at least 1 year.
Patients with Hoehn and Yahr staging from 2 to 4
Patients with MMSE score from 10 to 24
Patients who have taken donepezil for at least 12 weeks before screening period
Patients whose medications for Parkinson's disease have not change for 1 month
Patients who give informed consent

Exclusion criteria :

Patients who cannot be performed neuropsychiatric test because of hearing and visual difficulty
Patients who have taken medicine affecting cognitive function such as anticholinergic drug and memantine -Patients diagnosed as dementia with Lewy body and vascular dementia-
Patients who have history of neurosyphilis, head trauma, encephalitis or other movement disorders
Patients who have psychiatric disease
Except patients who are stable state under antidepressant or atypical neuroleptics
Patients with child-bearing periods
Patients who have severe liver or kidney disease necessary for aggressive treatment
Patients who have gastrointestinal disease needed for treatment
Patients who cannot taken tablet per oral
Patients who are participated in other clinical trial except observational study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sangjin Kim, Professor	Contact	82-51-797-8736		jsk120@hanmail.net

Overall Officials

Name	Affiliation	Role
Sangjin Kim, Professor	Inje University Haeundae Paik Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Inje university, busan paik hospital	Recruiting	Busan			South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15965198	Background	Ravina B, Putt M, Siderowf A, Farrar JT, Gillespie M, Crawley A, Fernandez HH, Trieschmann MM, Reichwein S, Simuni T. Donepezil for dementia in Parkinson's disease: a randomised, double blind, placebo controlled, crossover study. J Neurol Neurosurg Psychiatry. 2005 Jul;76(7):934-9. doi: 10.1136/jnnp.2004.050682.
14716693	Background

ID	Term
D010300	Parkinson Disease
D003704	Dementia

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D007189	Indans
D007192	Indenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic